Today In Alt Med

Ron Teeguarden & Dragon Herbs Warned By FDA

Ron Teeguarden and his company, Dragon Herbs, are taking another trip around the FDA's dance floor. This morning the US Food and Drug Administration published its August 15, 2012, warning letter to Teeguarden, informing him that more than a dozen of his herbal concoctions are in violation of the Federal Food, Drug and Cosmetic Act.

I don't know how long Teeguarden has been in the FDA's crosshairs but an FDA letter to Teeguarden from 2004 suggests that he and the agency are anything but strangers. Teeguarden's original correspondence to the agency has not, as far as I can tell, been made public but it seems that Dragon Herbs was seeking to make therapeutic claims for 2 of its products. The FDA denied those requests.

This time the products have names like  Supreme Protector and Super Pill. The full list of products that the FDA says are being hawked with un-allowed medical claims is:

• CardioPro 2000
• Cordyceps
• Duanwood Reishi
• Gynostemma
• Ginseng and Astragalus Combination
• Dang Gui and Gelatin
• Sweet Relief
• Remove Stagnation
• Bupleurum and Dragon Bone
• Amolo Tea
• Activated Minor Bupleurum
• Standardized Scute
• Salacia
• Shou Wu Formulations
• Ant Essence Capsules
• Ten Complete Supertonic
• Super Adaptogen
• Endocrine Health
• Supreme Protector
• Super Pill

The allegedly bogus claims appear on the DragonHerbs.com website as well as the Ron Teeguarden catalog. The list of claims is too extensively to adequately cover here and the FDA says that its letter to Teeguarden isn't intended to be all-inclusive. But even if the claims weren't in violation of The Act, Dragon Herbs would still be in trouble because some of the medical conditions for which they're touted aren't the kinds of things the average person is capable of diagnosing and treating himself, anyway--like HIV.

The FDA's warning letter to Ron Teeguarden and Dragon Herbs gives the company the standard 15 working days to either remove the violating claims or present its rebuttal to the agency. I couldn't get my hands on a catalog but I did take a look at the website. As of my visit early this afternoon I found the claims I looked up--like the one for his Minor Burplerum product, "demonstrated conclusively to have excellent anti-viral functions in humans with no side effects"--to be still there.

Colloidal Silver Peddler Lewis Blodgett Gets FDA Warning Letter

Since 1999 colloidal silver products have been officially deemed by the US Food and Drug Administration to be "not generally recognized as safe" and any product made with them is treated as "misbranded". But that has not stopped dozens and dozens of people from schlepping the stuff around the internet, claiming it treats everything from fungal infections to prostate cancer. And one of those hucksters just got an official warning letter for his efforts.

This morning the agency made public a copy of its August 15, 2012, warning letter to Healing Ways and its owner, Lewis David Blodgett. In it Blodgett is accused of using his website, healingways.com to peddle his colloidal silver as well as a powdered shell product and a "detox" program built around aloe vera and psyllium.

Blodgett, according to his website is a student of both John Christopher and Bernard Jensen. Christopher was the founder of the unaccredited School of Natural Healing in Utah. (The "school's" website isn't even an .edu.)  Jensen is perhaps best known for his advocacy of a type of pseudoscience called iridology in which practitioners claim to be able to diagnose diseases simply by examining the iris of your eye.

The FDA isn't impressed with Blodgett's credentials, though, and regard his shell powder, his colloidal silver and his detox program as "misbranded" and "new drugs". His colloidal silver product, for example is hawked for enlarged prostate, shingles and infections caused by bacteria, viruses and fungi.

His shell powder product is even more amazing. Although I can't find any info on just what kind of shells are ground up to make this miracle-in-a-jar I can tell you that Blodgett says it will treat skin disorders, joint problems, diabetes, high cholesterol and high blood pressure.

By contrast the claims made about Blodgett's ABC Detox Program seem downright tame. This system promises only to get rid of toxins, help you shed a few pounds, increase your energy and get rid of symptoms of "dis-ease," whatever "dis-ease" is supposed to mean.

The FDA says that none of the products has ever been proven safe or effective for any of the medical conditions for which they're touted but even if they were Blodgett would still be in trouble with the agency because things like enlarged prostate, diabetes and high blood pressure aren't things the average person can accurately and fully diagnose by himself or treat with home remedies, anyway.

The agency also has a big problem with some of the patient "testimonials" Blodgett is using on his website. Some of those get even more dramatic than the claims Blodgett himself makes. "E.C." says that the colloidal silver healed up his oral "cancer sore" while "Sister Rosemarie" says that spraying the stuff up her nose cured her "running fawcett". 

And, finally, the FDA informed Blodgett that his facility should be registered as a food facility. It is not.

The FDA warning letter to Healing Ways and its owner Lewis Blodgett lists many other examples of alleged violations of the Federal Food Drug and Cosmetic Act and the agency stresses that the letter is not intended to be all-inclusive. Blodgett has 15 working days to respond to the FDA's accusations of selling "misbranded" drugs and 30 days to register as a food facility.

FDA Barks at Parrillo For Sloppy Bookkeeping

Back in February agents with the Food and Drug Administration, or FDA, paid a multi-day visit to the manufacturing and packaging plant of Parrillo Performance. Early this morning the agency made available a copy of the August 13th warning letter that resulted from that inspection.

The violations spelled out in the FDA's official warning letter to Parillo Performance seem pretty tame--at least compared to some of the other letters we've seen recently. Essentially, it comes down to some pretty shoddy paperwork. The company is accused, for example, of failing to test its raw ingredients to guarantee that what Parillo thinks it's using is the ingredient that actually winds up in the finished products.

The company was also accused of not keeping complete master batch records; they are required to do so under current FDA regulations. Missing are notes about equipment maintenance, finished product testing and similar issues. Parillo also apparently told the FDA inspectors that the company doesn't keep master manufacturing records, either.

Cleanliness may be Parrillo's biggest problem--at least as far as it's customers are concerned. An employee was observed by inspectors reaching "elbow-deep" into a vat after sanitizing only his arms and wrists. Another was seen "reaching" into a mixing bowl while wearing jewelry and a couple of others were caught not wearing nets over their facial hair.

Parrillo, which markets protein bars, nutritional shakes and similar products for body builders and other "strength" athletes, apparently tried to respond to the FDA's concerns back in March. Unfortunately, says the FDA, the company's response was "inadequate" because it was not complete enough.

Parrillo Performance was given the standard 15 working days to respond to the FDA's letter.

Grato Warned For Several Products & Numerous Claims

Jesse Rettig and the company he runs, Grato, Inc., has been warned by the US Food and Drug Administration, or FDA, for numerous therapeutic claims the company was making about several of its products. Yesterday the agency made public a copy of that warning letter and we learn that these are the products the agency found troubling:

• Vital Male Sexual Energy  
• Vital HGH Skin Hair Nails
• Vital HGH Immune Booster
• Vital HGH
• TilillitusDX
• Fibro Relief
• AR Arthritis

Five of the products have been deemed "new" drugs by the agency because they've never been officially recognized by the FDA as safe or effective for the conditions for which they're peddled. And those same drugs can't hide under the homeopathic exemption, either, because they contain "active" ingredients that are not recognized in major homeopathic texts. "Homeopathic" ingredients like testosterone, human growth hormone and shark cartilage are among the decidedly non-homeopathic components listed by the FDA.

But even if they were, they would still be deemed "misbranded" because many of the conditions they claim to treat aren't medical conditions a layperson can accurately diagnose anyway, adds the agency.

This warning was apparently the result of previous inspections that took place at what the FDA refers to as "subsidiaries" of Grato. During these inspections agents with the FDA noted "numerous" violations of the Current Good Manufacturing Practice guidelines. Back in March Grato was issued a Form 483 which the FDA alleges the company has ignored.

And some of the things the agents say they found are troublesome. Grato allegedly refused to pull batches of an unnamed remedy after finding metal shavings in another batch. The company never explained why it felt it was OK to release product associated with the contaminated batch.

The company also apparently ignored 19 customer complaints of "broken, leaking or damaged" bottles of products. Again, the FDA accuses Grato of never explaining why it felt an investigation into those complaints was not needed.

There are numerous other allegations and the FDA did, as is normal with these kinds of warning letters, say that its warning letter to Grato was not intended to list every possible violation. And it did, of course, give the company 15 working days to respond.

I covered this warning letter earlier today for our sister site, TodayInHomeopathy.com and while I was there I found the claims for the male sexual product (like fatigue and desire) still there. And this afternoon I found "human growth hormone" still listed among the ingredients for the company's VITAL HGH Skin, Hair, Nail product, too.

Lithia Mineral Water Gets FDA Warning Letter

What do you get when you start promising people that your water cures viral infections, lowers cholesterol and heals the brain? If you're the CEO of Lithia Mineral Water, Inc. you get yourself an official warning letter from the US Food and Drug Administration.

This morning the agency made a copy of its July 20, 2012, warning letter to Lithia Mineral Water and the company's CEO Ian Simpson public. In it we see some pretty bold claims. Consider these promises, which inspectors say they found on the company's website, lithiamineralwater.com:

• Lower LDL Cholesterol
• Lower Blood Pressure
• Heal the Brain
• Combating Infections

Lithia certainly isn't shy about going after the seriously or chronically ill either. Some of the diseases and conditions it claims to be beneficial for include:

• Parkinson's
• Alzheimer's
• Cancer
• Diabetes
• Autism
• Fibromyalgia
• Bi-Polar Disorder

The FDA (of course) says that Lithia Mineral Water is neither safe nor effective for any of those conditions. And even if it was, the water would still be deemed "misbranded" because Parkinson's, caner and those other conditions aren't the kinds of things the average person can accurately diagnose or successfully treat with home remedies, anyway.

The company was also warned about "testimonials" agents say they found on the website. One supposed customer recommends it for arthritis; another, for autism in children.

And the company was also warned for referencing a scientific study on lithium as a segue to suggesting that minerals in Lithia might also be beneficial for dementia and other conditions.

Finally, the company was warned for simply trying to hawk water as a dietary supplement in the first place. Bottled water is already covered under the agency's "conventional food" umbrella--it can't also be a dietary supplement. (There's also some question about the "silver" claim but the FDA is giving Lithia a few days to respond to that one.)

The FDA closed its lengthy warning letter to Lithia Mineral Water, Inc. by reminding the company's CEO that this letter is not intended to be a full list of all the potential violations of the Federal Food, Drug and Cosmetic Act that the product could be committing. The company has the standard 15 working days to address the agency's allegations.

As of my visit to the company's website this afternoon I found the site's front page still bearing claims like "increases human life span," "stimulates brain cell growth"  and "reduces depression". A case of 12 bottles of Lithia Mineral Water is currently selling on Amazon.com for nearly $30.

Bacteria Found In Triple Lanolin's Aloe Vera Foot Scrub

OK, so maybe Vienna Beauty's Triple Lanolin brand of Aloe Vera Foot Scrub isn't actually marketed as a "natural" cosmetic but that doesn't make its bacterial contamination any easier to stomach. This morning the US Food and Drug Administration, or FDA, released a copy of its May 17 warning letter to Vienna Beauty and from it we learn that inspectors found not one, but two potentially deadly bacteria in the product.

According to the FDA's warning letter to Vienna Beauty Products agents with the FDA spent a few days at the company's manufacturing plant back in October, November and December of 2011. The warning letter doesn't say what, exactly, prompted the inspection; it characterizes the visit as a way simply to "determine" the company's "compliance" to laws governing the manufacturing and marketing of cosmetics and toiletries.

What the inspectors say they found, however, were multiple violations of the Federal Food, Drug and Cosmetic Act. Raw materials were not being routinely tested for purity, for example, and the water used to make cosmetics was not being routinely tested, either. And speaking of raw materials, inspectors say that those ingredients were not being handled in a way that minimized the chance of contamination. The same was true for packaging materials. Finally, the building itself was in need of repairs to prevent contamination of finished products.

So were inspectors shocked to find what they called "significant" levels of 2 different types of bacteria in samples of the company's Triple Lanolin Aloe Vera Foot Scrub? I don't know but I do know that neither bacterium is something you want to put on your skin. Pseudomonas aeruginosa, for example, is a germ that is naturally resistant to many of our first-line antibiotics. It is especially dangerous to very young babies, AIDS patients and anyone else with a compromised or weakened immune system. A small 2011/2012 outbreak in the US was ultimately traced to ultrasound gel that should have been sterile.

The other type of bacteria inspectors found is even a bit more worrisome. Known as Burkholderia cepacia complex, these pathogens are linked to arthritis, meningitis and blood infections and infections of the urinary and respiratory tracts--among other things. Bacteria in this group are also resistant to some of our most common antibiotics. In fact, it's so resistant that it can even live in things like antibacterial mouthwash--as it did during a recent outbreak in Germany.

From the FDA's warning letter we learn that the company has already addressed at least some of the agents problems found during the inspection. Unfortunately the agency says that that response is "inadequate" because the company didn't fully spell out the corrections it planned to make.

I can't find any evidence that the allegedly contaminated foot scrub ever reached the US market. The FDA appears to have no record of any recall for a product by that name.

Mojo Nights Peddler Warned For Drug Contamination & More

The company behind products like Mojo Nights, Sandman and Red Dawn has been formally warned by the US Food and Drug Administration, or FDA, for numerous problems found with those products--and more. Just about a year inspectors with the agency paid a multi-day visit to Evol Nutrition Associates' plant in Kennesaw, Georgia. The result of that inspection--an official warning letter to Evol and its owner, Jeremy Nickels--was made public last week.

A big chunk of the warning letter was devoted to Evol's Mojo Nights product. FDA tests on the supplement found tadalafil and sildenafil in it. (Tests also found multiple drug analogues.) You know tadalafil better as Cialis and sildenafil better as Viagra. Both are prescription-only pharmaceuticals prescribed primarily to treat erectile dysfunction. They are not allowed to be sold over-the-counter and they most certainly are not allowed to be put into dietary supplements. Of course, neither of those drugs was disclosed on the Mojo Nights label. Instead, the product is peddled as "100% Natural" and "herbal" with none of the "harmful side effects" of prescription drugs.

But even without the contamination, Mojo Nights would be in hot water with the FDA because it's clear, says the agency, that Evol is not touting the product simply as a supplement at all. Claims like "stop premature ejaculations" and "powerful erections" make it clear that Mojo Nights is being sold as a drug. And that puts it in even further violation of current drug laws.

Evol's problems with the agency don't stop with the one product, though. Several of its supplements are clearly being marketed as alternatives to street drugs like ecstasy. Claims like "enjoy having your head in the clouds" and "designed to heighten euphoric pleasure" make it clear, accuses the FDA, that these are intended to replace illicit party drugs. They are clearly not being marketed as dietary supplements AND they contain the nootropic drug piracetam. This means that Evol's Sandman Party Powder Euphoric Drink Mix, SleepWalker Euphoria Awareness Enhancer and Spark 4D Happy Caps are all illegal.

There were other allegations (and allegations about additional products) made by the FDA in its warning letter to Evol Nutrition and the agency was quick to warn the company that the letter was not intended to serve as a complete list of all the company's potential violations of the Federal Food, Drug and Cosmetic Act. (It is, after all, a company's responsibility to make sure its products are safe and legal.) But the letter did give Evol Nutrition Associates 15 working days to address the FDA's concerns.

The FDA's warning letter to Jeremy Nickels and Evol Nutrition Associates was dated July 10, 2012. As of my visit to one of the websites mentioned in the letter this morning, reddawnparty.com, I found claims like "give you powerful erections", "stop pre-mature ejaculations" and "jump start your sex drive" still visible on the Mojo Nights for Him sales page.

Stacey Miller & Alistrol Health Get Lengthy FDA Warning Letter

Anytime I see a "naturopath" who seems to be going out of her way to keep her education a secret I get . . . curious. But Stacey Miller's unwillingness to put her CV on any of her websites is the least of her worries right now. Last month the Food and Drug Administration, or FDA, sent Miller, her company, Alistrol Health, and her business partner, Steven Kalia, an official warning letter accusing them of making numerous bogus claims about 4 different products hawked on 6 different websites. This morning the agency made that letter public.

Back in June inspectors with the FDA paid a virtual visit to Miller via 6 of her websites. Those sites were:

• www.alistrol.com
• www.alistrol.net
• www.drophighbloodpressure.com
• www.highbloodpressure-treatment.net
• www.naavudi.com
• www.depressionfighters.com

On those sites the agents found multiple instances of what they characterized as "therapeutic" claims that supplements like the ones Miller touts just are not allowed to make. And because they make medical claims the products cease to be supplements and now fall under the "drug" umbrella, says the agency.

For example, Miller's Alistrol supplement is peddled mainly for high blood pressure and does it, according to one of Miller's websites, "as effectively as possible". Alistrol also promises to "break down" fat and cholesterol. It is supposedly based on traditional Chinese remedies and combines garlic, Hawthorn berry, daikon and Chinese holly.

But if you have a little more money to spend you could always, says Miller, combine the Alistrol with another of her products--CLE Vitamin D3. That one promises a "double-barrelled [sic] attack on your high blood pressure". It may also be "beneficial" for "some" cancers.

Then there's the Naavudi product. This is supposedly based on an old Ayurvedic herbal remedy and made with something Miller calls epicatechin. Epicatechin isn't actually a plant, though; it's actually what scientists call a type of antioxidant found in plants. Naavudi is promoted as a diabetes remedy.

And if all this talk about diabetes, cancer and high blood pressure has you feeling blue there's a pill for that, too. Depression Fighters was designed to be a "natural" alternative to drugs like Zoloft and Prozac.

The FDA, of course, says that none of those products has ever been proven effective for any of those conditions. That means, as far as the agency is concerned, Alistrol Health is selling new and unapproved drugs. Alistrol's products are in even more trouble, though, because they're being promoted for medical conditions the average person can't self-diagnose or successfully treat without a doctor's help, anyway.

And the FDA's problems with Stacey Miller doesn't end there. Testimonials are considered marketing spiel by the agency and Miller's websites have no lack of them. The sites also contain "hidden" web code called meta tags that make even more claims, says the FDA. The company's Facebook also contains postings that make unallowed medical claims.

Its standard practice for the Food and Drug Administration to give companies like Alistrol Health 15 working days to either remove the offending therapeutic claims or respond to the agency's concerns and that's exactly what's happening here. The FDA's warning letter to Alistrol Health and Stacey Miller was dated June 26, 2012. As of my visit to the websites this morning I found the claims I looked up still there.

Good Herbs Warned For Sloppy Record Keeping & Bogus Claims

Good Herbs Inc. is in hot water with the US Food and Drug Administration over some apparently sloppy record keeping and therapeutic claims the agency say go way beyond the claims companies can make about herbal remedies. And the FDA spelled it all out in an official warning letter to the company back in May.

Today the agency made that warning letter public and it is a lengthy one.

Between November of 2011 and January of this year FDA inspectors spent an unspecified number of days at Good Herbs' manufacturing plant in Troy, Michigan. During those visits the agents noted a number of what they deem "significant" violations of the Federal Food, Drug and Cosmetic Act. For example, when Good Herbs was asked for its records the company was unable to pony up identity specifications for its ingredients. It was also unable to produce documentation on its finished products proving purity, strength or even the supplements' actual ingredients. Those are all violations of Title 21 of the Federal Code of Regulations.

From the FDA's warning letter to Good Herbs we learn that the company tried to address those allegations in late January. However, the agency found the response "inadequate" because the company did not provide any actual documentation that it was making changes.

Good Herbs was also warned about medical claims that the FDA says the company is not allowed to make about herbal supplements. Good Herbs sends its customers a booklet titled A Practical Guide To Herbs that touts the company's products for a variety of medical conditions. Its AquaActive Tablets, for example, are peddled for high blood pressure and diabetes while its Capsicum 90 product makes claims about erectile dysfunction, restless leg syndrome, brain damage and more.

In all, 8 products were specifically mentioned in the warning letter. Those include:

• AquaActive Tablets 
• Capsicum 
• Echinacea
• HR-2
• IMB-T PLUS 
• Olive Leaf
• PARA-2-L
• PO-K

The FDA, of course, says that none of the products has ever been proven safe or effective for the medical conditions for which they're proclaimed and that makes them "new" an "unapproved" drugs in the agency's eyes.

But even if Good Herbs could prove the products effective they would still be "misbranded" because conditions like erectile dysfunction, heart disease and toxic shock syndrome aren't things the average layperson can treat without medical help, anyway. And sticking on a disclaimer like the one Good Herbs tried to use doesn't absolve them of any responsibility, either, adds the agency.

The FDA stresses that its warning letter to Good Herbs was not intended to provide a full list of all of Good Herbs' potential violations.

The company was given 15 working days to respond. 

Rockstar Warned For Herb-Spiked Coffee

The US Food and Drug Administration, or FDA, gets a mite particular when it comes to companies hawking "functional foods" and this week it's coffee maker Rockstar, Inc. which finds itself in the agency's crosshairs. Just moments ago the agency released a copy of its May 23, 2012, warning letter to Rockstar and CEO Russell Weiner.

From the letter we learn that back in January the agency stopped by Rockstar's manufacturing plant in Livingston, Tennessee. During that inspection agents took samples of several of Rockstar's labels and found various labeling violations on them. Most of those alleged violations come down to one thing--Rockstar is promoting its coffee drinks as dietary supplements while also presenting them as food.

Under current FDA regulations a supplement is not considered a supplement if it's used as a meal or presented as a "conventional" food. The FDA finds that Rockstar's coffees, which come in 8, 16 and 24 ounce cans, are being peddled in just such a fashion. The agency cites Rockstar's use of verbiage like "refreshing beverage" and "coffee" as language that takes the drink from under the supplement umbrella and places it firmly in food territory.

The agency also has a problem with Rockstar's use of Ginkgo in its drinks. Ginkgo biloba may be a popular herbal remedy but it's not, says the FDA, an approved food additive. And that means that the FDA officially sees it as "unsafe" in food.

As is usually the case, Rockstar, Inc was given 15 working days to correct the alleged violations and respond to the FDA's letter. As of my visit to what I believe is Rockstar's official website, rockstar69.com, I found Ginkgo still listed as an ingredient on the site's Products page. Its Facebook and Twitter pages, which have both been updated today, also seem to be ignoring the release of the warning letter.